A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)
- Conditions
- Ulcerative Colitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT06137183
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of vixarelimab compared with placebo in participants with moderate to severe UC who have demonstrated inadequate response to, loss of response to, or intolerance to prior conventional or advanced therapy.
- Detailed Description
This study consists of two periods:
1. An induction period which will test the induction of clinical remission;
2. An optional active treatment extension (ATE) period which will explore durability of clinical response and remission in which all participants will receive vixarelimab.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 79
- Diagnosis of UC for at least 3 months
- Moderately to severely active UC, assessed by mMS
- Inadequate response, loss of response to, or intolerance to conventional or advanced therapies for UC
- Diagnosis of Crohn's disease or indeterminate colitis
- Suspicion of ischemic, radiation, microscopic, or infectious colitis
- Prior colectomy
- Inadequate response or loss of response to previous treatment of UC with tofacitinib, upadacitinib, or other systemic janus kinase (JAK) inhibitor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period. Vixarelimab Dose Regimen 1 Vixarelimab Participants will receive vixarelimab subcutaneously (SC) during the induction period and the optional ATE period. Vixarelimab Dose Regimen 2 Vixarelimab Participants will receive vixarelimab SC during the induction period and the optional ATE period. Placebo Vixarelimab Participants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period.
- Primary Outcome Measures
Name Time Method Proportion of Participants With Clinical Remission Week 12 Clinical remission is defined as the Modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore of ≤ 1, rectal bleeding subscore of 0, and endoscopy subscore of ≤ 1. The mMS is a composite of stool frequency, rectal bleeding, and endoscopy with each component having a scoring range of 0-3. The mMS has a total score range of 0-9 with higher scores indicating greater disease severity.
- Secondary Outcome Measures
Name Time Method Proportion of Participants With Clinical Response Week 12 Clinical response is defined as decrease from baseline in the mMS by ≥2 and ≥ 30% reduction from baseline, with either a decrease of ≥1 in the rectal bleeding subscore or an absolute rectal bleeding subscore of ≤1. The mMS is a composite of stool frequency, rectal bleeding, and endoscopy with each component having a scoring range of 0-3. The mMS has a total score range of 0-9 with higher scores indicating greater disease severity.
Proportion of Participants With Endoscopic Improvement Week 12 Endoscopic improvement is defined as a mayo endoscopy subscore of ≤ 1. Mayo endoscopy subscore has a score range of 0 (normal appearance of mucosa) to 3 (severe disease).
Proportion of Participants With Endoscopic Remission Week 12 Endoscopic remission is defined as a mayo endoscopy subscore of 0. Mayo endoscopy subscore has a score range of 0 (normal appearance of mucosa) to 3 (severe disease).
Number of Participants With Adverse Events (AEs) by Severity Up to Week 56 The AEs will be graded according to the Division of AIDS (DAIDS) table for grading the severity. The toxicity level is graded from grade 1 (lowest toxicity) to 4 (highest toxicity).
Serum Concentration of Vixarelimab Up to Week 56 Proportion of Participants With Anti-drug Antibodies (ADAs) to Vixarelimab Up to Week 56
Trial Locations
- Locations (123)
Sheba Medical Center - PPDS
🇮🇱Ramat Gan, Israel
Gulf Coast Gatroenterology
🇺🇸Fairhope, Alabama, United States
Pesquisare Saude
🇧🇷Santo Andre, São Paulo, Brazil
Praxis Pesquisa Médica
🇧🇷Santo Andre, São Paulo, Brazil
Hospital Sirio-Libanes
🇧🇷Sao Paulo, São Paulo, Brazil
Hospital Universitario Clementino Fraga Filho - UFRJ
🇧🇷Rio de Janeiro, Brazil
West China Hospital - Sichuan University
🇨🇳Chengdu City, China
Wuxi People's Hospital
🇨🇳Wuxi, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, China
SurGal Clinic s.r.o.
🇨🇿Brno, Czechia
Hepato-Gastroenterologie HK, s.r.o.
🇨🇿Hradec Kralove, Czechia
PreventaMed s.r.o.
🇨🇿Olomouc, Czechia
Endohope klinika s. r.o.
🇨🇿Praha, Czechia
CHU Nice - Hopital de l'Archet 2
🇫🇷Nice Cedex 3, France
Hospices Civils de Lyon Centre hospitalier Lyon Sud
🇫🇷Pierre Benite, France
CHU de Saint-Etienne - Hopital Nord
🇫🇷Saint Etienne, France
CHU de Nancy-Hopital Brabois Adulte
🇫🇷Vandoeuvre les Nancy, France
Charite - Campus Benjamin Franklin
🇩🇪Berlin, Germany
Universitaetsklinikum Halle (Saale)
🇩🇪Halle, Germany
Universitatsklinikum Schleswig-Holstein - Kiel
🇩🇪Kiel, Germany
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Evangelismos General Hospital of Athens
🇬🇷Athens, Attiki, Greece
Sotiria General Hospital of Athens
🇬🇷Athens, Greece
Alexandra Hospital
🇬🇷Athens, Greece
University General Hospital of Heraklion
🇬🇷Heraklion, Greece
Iatriko Palaiou Falirou
🇬🇷Palaio Faliro, Greece
Tzaneio General Hospital
🇬🇷Piraeus, Greece
Rambam Health Care Campus
🇮🇱Haifa, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
🇮🇹Bologna, Emilia-Romagna, Italy
Fondazione Policlinico Universitario A Gemelli-Rome
🇮🇹Roma, Lazio, Italy
Ospedale San Raffaele S.r.l. - PPDS
🇮🇹Milano, Lombardia, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Lombardia, Italy
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
🇵🇱Warszawa, Poland
Melita Medical
🇵🇱Wroc?aw, Poland
PlanetMed
🇵🇱Wroc?aw, Poland
Przychodnia VISTAMED
🇵🇱Wroc?aw, Poland
University Clinical Center of Serbia -PPDS
🇷🇸Beograd, Belgrade, Serbia
Clinical Hospital Center Dragisa Misovic Dedinje
🇷🇸Belgrade, Serbia
Military Medical Academy
🇷🇸Belgrade, Serbia
Clinical Hospital Center Bezanijska Kosa
🇷🇸Beograd-zemun, Serbia
Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Clinical Centre of Vojvodina
🇷🇸Nova Sad, Serbia
Clinical Hospital Centre Zemun
🇷🇸Zemun, Serbia
Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
🇨🇳Niaosong Dist., Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
General Hospital Djordje Joanovic - Zrenjanin
🇷🇸Zrenjanin, Serbia
E-Da Hospital
🇨🇳Kaohsiung, Taiwan
Centrum Medyczne UNO-MED-Tarnow
🇵🇱Tarnów, Poland
Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna
🇵🇱Kraków, Poland
Allmedica Badania Kliniczne sp. z o.o. sp.k.
🇵🇱Nowy Targ, Poland
Office of Jaroslaw Kierkus, Dr n Med
🇵🇱Otwock, Poland
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Endoskopia Sp. z o.o.
🇵🇱Sopot, Poland
Sonomed Sp. z o.o.
🇵🇱Szczecin, Poland
NZOZ FORMED sp zo.o.
🇵🇱Wadowice, Poland
Centrum Zdrowia MDM
🇵🇱Warszawa, Poland
OM Research LLC - Camarillo - ClinEdge - PPDS
🇺🇸Camarillo, California, United States
UCLA Clinical and Translational Research Center
🇺🇸Los Angeles, California, United States
Facey Medical Foundation - Mission Hills
🇺🇸Mission Hills, California, United States
Clinical Applications Laboratories, Inc.
🇺🇸San Diego, California, United States
Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Regenerate Primary Medical
🇺🇸Miami, Florida, United States
Advanced Research Institute, Inc.
🇺🇸New Port Richey, Florida, United States
Orlando Gastroenterology, P.A.
🇺🇸Orlando, Florida, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Henry Ford Health System
🇺🇸Novi, Michigan, United States
Mayo Clinic - PPDS
🇺🇸Rochester, Minnesota, United States
Delta Gastroenterology & Endoscopy Center
🇺🇸Southaven, Mississippi, United States
Strong Memorial Hospital
🇺🇸Rochester, New York, United States
Carolina Digestive Diseases
🇺🇸Greenville, North Carolina, United States
Ohio Gastroenterology and Liver Institute
🇺🇸Cincinnati, Ohio, United States
North Shore Gastroenterology
🇺🇸Westlake, Ohio, United States
Tyler Research Institute, LLC
🇺🇸Tyler, Texas, United States
University of Utah - Health Sciences Center - PPDS
🇺🇸Salt Lake City, Utah, United States
CHU St Pierre (St Pierre)
🇧🇪Bruxelles, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Cliagen Clinica de Atençao em Gastroenterologia, Especialidades e Nutriçao
🇧🇷Salvador, Bahia, Brazil
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
🇧🇷Brasilia, Distrito Federal, Brazil
Centro Digestivo de Curitiba
🇧🇷Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre HCPA PPDS
🇧🇷Porto Alegre, Pará, Brazil
Associacao Hospitalar Moinhos de Vento
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital das Clinicas da Faculdade de Medicina de Botucatu (HCFMB)
🇧🇷Botucatu, São Paulo, Brazil
Centro de Estudos Clinicos do Interior Paulista
🇧🇷JAU, São Paulo, Brazil
Kaiser Hospital Dia
🇧🇷Sao Jose Do Rio Preto, São Paulo, Brazil
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou City, China
Jinhua municipal central hospital
🇨🇳Jinhua City, China
The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)
🇨🇳Ningbo City, China
Shengjing Hospital of China Medical University
🇨🇳ShenYang, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou City, China
The Sixth Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, China
Qilu Hospital of Shandong University
🇨🇳Jinan, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan City, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, China
Azienda Ospedaliera Ordine Mauriziano di Torino
🇮🇹Torino, Piemonte, Italy
Azienda Ospedaliero - Universitaria di Cagliari
🇮🇹Monserrato, Sardegna, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
🇮🇹Palermo, Sicilia, Italy
IRCCS Ospedale Sacro Cuore Don Calabria
🇮🇹Negrar, Veneto, Italy
Inje university Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
The Catholic University of Korea Daejeon ST. Mary?s Hospital
🇰🇷Daejeon, Korea, Republic of
Yonsei University Wonju Severance Christian Hospital
🇰🇷Gangwon-do, Korea, Republic of
Severance Hospital Yonsei University Health System - PPDS
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Puerta de Hierro Sur
🇲🇽Tlajomulco de Zúñiga, Jalisco, Mexico
Accelerium, S. de R.L. de C.V. - PPDS
🇲🇽Monterrey, Nuevo LEON, Mexico
Medical Care & Research SA de CV
🇲🇽Mérida, Yucatan, Mexico
Hospital Angeles Chihuahua
🇲🇽Chihuahua, Mexico
EuroMediCare Szpital Specjalistyczny z Przychodni? we Wroc?awiu
🇵🇱Wroclaw, Dolnoslaskie, Poland
Clinical Trials UMED Sp. z o. o.
🇵🇱?ód?, Poland
Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.
🇵🇱?ód?, Poland
Medical Center Kermed
🇵🇱Bydgoszcz, Poland
Polimedica PTG Kielce
🇵🇱Kielce, Poland
MZ Badania Slowik Zymla Sp.j.
🇵🇱Knurów, Poland
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
The Royal London Hospital
🇬🇧London, United Kingdom
Hammersmith Hospital
🇬🇧London, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom